Asia is rapidly becoming a new frontier for drug development as Western companies seek to develop and register their products in Asia, while emerging Asian companies seek new capabilities to globalize products. We hear a lot of positive sounds and enthusiasm from MNCs about the environment in Thailand: available pool of patients, less competing trials, a well educated and affordable working force. How would you describe the peculiarities of the clinical trial landscape in Thailand?
I have been here for eighteen months, and even during such a relatively short time I have already seen changes in the right direction. Speaking to colleagues that have been involved in research in Thailand for many years, I can confirm that these movements in the right direction have been going on over a longer period of time.
Quintiles is working hard to develop drugs faster and to a lower price so that the end user, the patients, can take advantage of those drugs. For us it hence comes down to timelines and how fast we can move through the regulatory process.
Quintiles’ Bangkok office is the company’s third largest South East Asian office outside of Singapore and South Korea. Would you outline the role and importance of the Thailand operations within the company’s South East Asia presence?
Thailand, at the center of Indochina, plays a vital role in the larger picture for Quintiles and the entire pharmaceutical industry looking at Asia as a key part of their commercial development. Previously the impression was that CROs were just looking for extra patients in Asia, whereas today we are doing trials for local and regional studies as well as global ones. We are also expanding to offer consulting and strategic drug development services in the region.
The Asian pharmaceutical market is set to exceed 120 billion USD by the end of 2012, representing a major proportion of the global market, and Thailand plays a part in that regional picture.
Quintiles decided to invest in Thailand earlier than many of its peers, which is undoubtedly part of the reason why the company has such a strong foothold in Thailand. What growth numbers do you see today?
Quintiles in Thailand now employs over 100 people spread over two offices, one in Bangkok and one in Chiang Mai. We expect to see continued growth in both locations as we incorporate other parts of the four Cs into the business in Thailand – commercial, clinical, capital and consulting.
The biggest proportion of our business today is clinical from clinical research associates and clinical trial assistance; conducting the hands-on clinical trials with the hospitals principal investigators and monitoring safety data. We also have a therapeutic delivery unit, which is project management. We have a regulatory division that takes care of relations with the Thai FDA, and we hold an import license to bring pharmaceutical products into Thailand.
We have a site start-up group which takes care of getting studies off the ground and of interactions with the authorities to get approvals.
We see greater demand and request from local customers both regionally but also within Thailand; we are setting up relations with some of the larger Thai pharmaceutical companies. Quintiles is building expertise within Thailand particularly around consulting and investment as we see future possibilities in that area.
The rising popularity of clinical trials in Thailand also leads to an increasingly intense competitive landscape, with many global CROs looking to establish or increase their presence; how would you rate the competitive landscape and how do you position Quintiles in this landscape to be the best?
Quintiles was the first major CRO to be established in Thailand, and today we are still the biggest. Within Quintiles we have a structured university process to educate people within clinical research and to create clinical research specialists. Within Thailand, the majority of people who work in clinical research commercially have had some contact with Quintiles at some point in time.
On the competitive front it is correct that other CROs have moved into Thailand, while there is a lot more local competition as well. I do not see it as very challenging competition though because most of the work comes globally at the moment.
A major challenge we do deal with is staff retention, which creates problems because there are a lot of opportunities in the Thai market. We have several initiatives running locally both in the business line and in cooperation with HR and talent management in Singapore. We work together to assess current concerns and trends within the market that we should be aware of and adapt to move with the trends.
As a result of growth and competition in clinical trials, we see that pharmaceutical companies are looking for clinical specialists themselves now in setting up their own clinical centers, and of course the first place that anyone looks for specialists are the biggest CROs. We therefore work hard to continuously motivate our people and show an attractive future. The great thing about Quintiles is that, apart from local development in different areas, we can also offer regional and global movement. We need to make sure that we keep providing staff with challenges for their own development.
When we spoke to your counterpart in Indonesia, Mr. Klein, he told us that there is an ever greater convergence between clinical and commercial across the product life cycle, and that a commercial mindset earlier in the clinical development process is required. How well is Quintiles Thailand placed to help customers with that?
As part of the New Health and the Quintiles strategies that we have adopted since 2010, we are focusing very much on the end point, and not just on the here and now. Globally throughout the organization we have a focus on the whole pathway, from beginning of development to marketing. Most of our people in Thailand have a pharmaceutical background and understand how things work from a marketing, prescribing and reimbursement perspective, and everybody has the end goal in sight.
Thailand is known to be very strong in phase 3 & 4 clinical research; but our readers are curious to see phase 1 & 2 take off as well. Do you believe Thailand has what it takes and what needs to be done to speed up this part?
There is definitely potential. To unlock we need additional infrastructure development. Quintiles has also recently invested in a large phase-I unit in India for example.
When we met with Dr. Pipat of Thai FDA, he told us that his organization is implementing new regulation to further improve the environment for clinical trials in Thailand. How is your relationship with the regulatory authorities and what action would you like them to take to further improve the clinical trial landscape in Thailand?
Quintiles has good relationships and attend meetings with the Thai tech. We have had local events where we have worked with the Thai FDA and we have dedicated staff within the office which spends considerable time with the Thai FDA submitting and collecting documents.
The Thai FDA have already made positive changes; for example we can now submit documents electronically and the time lines are very fair; when we submit a document they commit and deliver and we get the approvals we need; overall I am very happy.
The regulatory process in Thailand is not so complex. It is the Thai FDA that gives approval in order to gain an import license at the clinical drug trial stage. The part that actually is more complex is the ethical approval. Thailand has a central ethics committee called the MOPH, and the Institute of Development of Human Resource Protection was set up a couple of years ago under the government of the MOPH. They have made a difference for clinical research: as a professional body to review clinical research applications, they are able to offer more competitive timelines in approval.
The problem we have seen recently is that they tend to have a waiting list, which might be a result of more organizations being interested in conducting clinical research in Thailand, which in turn resulted from an improved and less complex environment with more competitive timelines. Once you have submitted and got approval from the national EC, they need to give notification to the local EC and they would generally only comment on the language for example. The ethics process is also working very well; the only problem is the volume of work that the committee deals with at the current time.
Given the ongoing regulatory harmonization in preparation of the ASEAN Economic Community, what expectations do you have for multi-jurisdictional trials in the region?
Looking at ASEAN integration and the future of multi-jurisdictional clinical trials, I think it would be positively received in Thailand. However the Thai are very proud people; the country has never been colonized and is very self-sufficient. I think it will take a little bit of negotiation.
Thailand knows a rapidly developing biotechnology industry. What opportunities do you see for Quintiles to capitalize on this growth?
Definitely we see biotechnology as a growing sector within the business, globally, regionally, and also within Thailand. The authorities have also recognized the possibilities and the need to further develop this sector. Approval timelines are slightly longer but I do not see any obstacles to a bright future for biotechnology in Thailand.
If we were to come back three years from now, where will you have taken the operations of Quintiles in Thailand?
We are proud to adhere to very high quality standards in our work, and we will work hard to keep the quality of our work at such high standards. We already have a proven track record; our principals know that we deliver on time and that we deliver what we say we will. One area that we are focusing on is the relationships with the hospitals and the investigators. We have a global department that looks at certain hospitals and together we enter in an agreement under the Prime Site Program. We have five prime sites within the region, and in Thailand we see potential for example with Siriraj Hospital. It is definitely a symbiotic relationship; life is easier for both parties once we get to know each other and each other’s expectations.
What is your final message to the executive readers of our report about Quintiles commitment to bringing its top notch services to Thailand?
We have a well-established organization in Thailand with highly motivated clinical research specialists and are able to offer a broad range of services. We understand the regulatory environment and are able to deliver to customer expectations every time.
How did you, as an example of how Quintiles employees use the global opportunities that the company offers, find the transition from your previous locations in Scandinavia to Thailand and how did you adapt your management style?
The biggest difference is cultural: in Scandinavia it is a flat structure, there is no hierarchy, while in Thailand hierarchy plays an important role. It is about adapting and respecting local culture and about understanding the needs of staff and what motivates them. Continual development and visible opportunities are very important in this. Employees have to be aware of what is going on regionally and globally within the organization and have to be and feel part of that.